Catalogue


Writing clinical research protocols : ethical considerations /
Evan G. DeRenzo and Joel Moss.
imprint
Burlington, MA ; London : Elsevier Academic, [2006]
description
xix, 300 p. ; 23 cm.
ISBN
0122107519 (pbk.)
format(s)
Book
Holdings
More Details
added author
imprint
Burlington, MA ; London : Elsevier Academic, [2006]
isbn
0122107519 (pbk.)
standard identifier
9780122107511
contents note
Introduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience.
catalogue key
5761403
 
Includes bibliographical references and index.
A Look Inside
About the Author
Author Affiliation
Evan DeRenzo, Ph.D., is a bioethicist with the Center for Ethics at the Washington Hospital Center, Washington, D.C. Joel Moss, M.D., Ph.D., is Chief, Pulmonary-Critical Care Medicine Branch, and Chair, Institutional Review Board, National Heart, Lung, and Blood Institute at the National Institutes of Health (NIH)
Reviews
Review Quotes
"This book will be a very useful text and reference source for students and trainees at all levels, as well as for seasoned investigators and RERB members. The continuing proliferation of formal, degree-granting masters and doctoral training programs in clinical investigation at academic centers across the country underscores the need for a book like this. These programs, and the growing acceptance and recognition of professional certification programs for clinical research professionals, are indicators that the expectations we place on investigators are greater than they were just a few years ago. Recognition that good science and good ethics are inextricably bound together in clinical research is todays reality, and this book gives real insight into why and how."- JAMA (February 2006)
"This book will be a very useful text and reference source for students and trainees at all levels, as well as for seasoned investigators and RERB members. The continuing proliferation of formal, degree-granting masters and doctoral training programs in clinical investigation at academic centers across the country underscores the need for a book like this. These programs, and the growing acceptance and recognition of professional certification programs for clinical research professionals, are indicators that the expectations we place on investigators are greater than they were just a few years ago. Recognition that good science and good ethics are inextricably bound together in clinical research is today's reality, and this book gives real insight into why and how." - JAMA (February 2006)
"This book will be a very useful text and reference source for students and trainees at all levels..." - JAMA (February 2006)
To find out how to look for other reviews, please see our guides to finding book reviews in the Sciences or Social Sciences and Humanities.
Summaries
Bowker Data Service Summary
This practical guide for clinical researchers improves their understanding of the ethical requirements for the design and conduct of clinical research.
Long Description
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Main Description
A practical guide for clinical researchers that aims to improve their skills in the understanding of the ethical requirements for the design and conduct of clinical research. Includes information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocals approved, special populations, confidentiality issues, and the reporting of adverse events. Appendices include internet resources, grant writing tips, as well as advice on subject recruitment and budget considerations.
Main Description
In the last 50 years, there has been an exponential increase in the number of research studies, as well as greater media and public scrutiny of researchers and the research process. Writing Clinical Research Protocols: Ethical Considerations is designed to give researchers and research education programs a single source that investigators and support staff can use. This book includes a wide range of ethical considerations that need to be addressed in the course of designing and gaining approval for a human research study. The current literature on ethics for clinical researchers is limited. That which exists tends to focus on a particular area of research ethics, such as consent or Institutional Review Boards. This book offers the researcher guidelines on writing protocols from the perspective of the ethical judgments to be made within each section of the protocol and consent documents. Writing Clinical Research Protocols: Ethical Considerations thus fills a conspicuous void in the research literature. Book jacket.
Main Description
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol* Includes a chapter containing Case Histories* Contains information on conducting clinical research within the pharmaceutical industry* An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Table of Contents
Prefacep. xvii
The Basics: What You Need to Know Before Starting Human Subjects Researchp. 1
Introduction to the Art and Science of Clinical Researchp. 3
Clinical Research Definedp. 3
Clinical Research Ethics Definedp. 3
Oversight: Origins, Relevance, and Future Rolep. 4
How to Use This Bookp. 5
What You Need to Know About Clinical Research Ethicsp. 11
Intersections of Scientific Goals and Ethical Concerns: How Study Design Influences Evaluation of Ethical Aspectsp. 11
Landmark Documents in the Codification of Clinical Research Ethics: National and Internationalp. 14
The Basic Principles and Theories of Clinical Research Ethics: Learning How to Justify Study Designp. 18
Balancing Scientific Efficiency Against Subject Protection: Ensuring That the Balance Is Always Weighted in the Right Directionp. 24
What You Need to Know About the Regulation of Clinical Researchp. 27
U.S. and International Regulatory Oversight Bodiesp. 27
Radiation Safety Committeesp. 30
Institutional Review Boards and Other Ethics Research Review Bodies and Committeesp. 31
Variability Across IRBs and Other Reviewing Bodies: Those That Exist and Those of the Futurep. 34
Project Assurancesp. 35
Initial Approval and Continuing Reviewsp. 36
Data and Safety Monitoring Boardsp. 37
Disclosure and Minimization of Conflicts of Interest: Personal and Institutionalp. 38
Preparing the Protocolp. 41
Designing a Clinical Research Studyp. 43
Shaping the Study Question or Hypothesisp. 43
Selecting the Study Designp. 45
General Design Characteristicsp. 50
Beginning to Write the Protocolp. 59
Selecting Subjects for Clinical Studiesp. 63
Study Volunteers: Healthy Subjects or Patient Subjects?p. 64
Vulnerable Subject Populations: Who Is Classified as Vulnerable and How This Decision Is Madep. 65
Special Populations and Additional Protectionsp. 67
Writing the Protocol Section on Subject Selectionp. 95
Risks and Benefits in Clinical Researchp. 97
Weighing Risk of Harm Against Potential for Benefitsp. 99
Regulatory Requirements for Minimization of Riskp. 105
Study Procedures for Minimization of Riskp. 106
Completion of a Studyp. 111
Research-Related Injuriesp. 113
Maximizing Benefitsp. 113
Writing the Protocol Section on Risk, Burden, and Discomfortp. 116
Writing the Protocol Section on Benefitsp. 117
Recruiting Subjectsp. 119
Who Is Responsible for Recruiting Subjects?p. 120
When Does the Recruitment Process Begin and End?p. 122
Recruiting Subjects for Multiple Studiesp. 123
The Professional Research Subjectp. 125
Writing the Protocol Section on Recruitmentp. 125
Informed Consentp. 127
Traditions and Purpose of Informed Consentp. 127
When Does the Informed Consent Process Begin?p. 129
The Difference Between Process and Productp. 131
Required Elementsp. 133
Obtaining Valid Informed Consentp. 141
Writing the Protocol Section on Consent, Assent, and Surrogacy Permissionsp. 146
Writing Consent, Assent, and Surrogacy Permission Documentsp. 152
Privacy and Confidentialityp. 159
Traditions and Expectationsp. 159
Management of Subject Privacy and Protection of Confidential Informationp. 160
Provision to the Subject of Clinically Relevant Private Research Informationp. 163
Withholding Personal Information from a Study Subjectp. 168
Provision of Information at Study Conclusionp. 171
Release of Research Information to Othersp. 172
Certificate of Confidentialityp. 173
Writing the Protocol Section on Privacy and Confidentialityp. 173
Writing Privacy and Confidentiality Statements in Consent Formsp. 174
The "Ethics" Sectionp. 175
The Difference Between an Ethics Section and a Compliance with Ethics Regulations Sectionp. 175
An Existing Model of a Substantive Ethics Sectionp. 177
Writing a Substantive Ethics Sectionp. 178
Procedures, Methods, Statistics, Data Management, and Record Keepingp. 183
Procedures and Methodsp. 185
Randomizationp. 186
Blindingp. 186
Drug Testingp. 187
Surgical Trialsp. 193
Device testingp. 196
Assessmentsp. 197
Laboratory Studiesp. 199
Observational Methodologiesp. 200
Video and/or Audio Tapingp. 201
Quality-of-Life Measurementsp. 201
Follow-up Proceduresp. 202
Adverse Reactions and Adverse Eventsp. 203
Statistics, Data Collection and Management, and Record Keepingp. 207
Statisticsp. 207
Data Collection and Managementp. 215
Record Keepingp. 219
Special Issuesp. 221
Use of Human Biological Materialsp. 223
Anonymous, Anonymized, Coded, and Identifiable Specimensp. 223
Anticipated Present and Future Use(s) of Tissuep. 225
Tissue Samples from Those Who Are Deceasedp. 230
Writing the Protocol Sections on the Use and Storage of Human Biological Materialsp. 232
Special Issues Raised by Evolving Areas of Clinical Researchp. 237
Genetics Researchp. 237
Psychiatric Researchp. 245
Recruitment and Retention of Women and Minority Populationsp. 249
Involvement of Pregnant Women or Fetusesp. 250
Emergency Medicine Researchp. 251
Community-Based Researchp. 252
Quality Improvement and Quality Assurance Researchp. 253
Translational Researchp. 254
Epidemiological Researchp. 255
Surgical Researchp. 256
Biologicsp. 257
Prisonersp. 257
Clinical Research and Bioterrorismp. 258
Case Histories: Learning from Experiencep. 261
Classical Cases in Clinical Research Ethicsp. 262
Contemporary Cases in Clinical Research Ethicsp. 265
Web Resourcesp. 269
Referencesp. 273
Glossaryp. 281
Indexp. 291
Table of Contents provided by Ingram. All Rights Reserved.

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